Evaluation of a New Female Urinary Intermittent Catheter

Evaluation of a New Female Urinary Catheter Used for Intermittent Catheterization

A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.

Inclusion Criteria:

• Provision of signed and dated informed consent.
• Females aged 18 years and over.
• Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
• Practice intermittent catheterization at least 2 times daily.
• Use catheter size available in the study
• Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy.
• Adults able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

• Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
• Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
• Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
• Previous enrolment in the present study.
• Simultaneous participation in another clinical study that may impact the primary endpoint
• Expected or severe non-compliance to protocol as judged by the investigator and/or Wellspect.